The following data is part of a premarket notification filed by Xenco Medical, Llc with the FDA for Xenco Medical Cervical Interbody System.
| Device ID | K160313 |
| 510k Number | K160313 |
| Device Name: | Xenco Medical Cervical Interbody System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | XENCO MEDICAL, LLC 9930 MESA RIM ROAD San Diego, CA 92121 |
| Contact | Gustavo Prado |
| Correspondent | Gustavo Prado XENCO MEDICAL, LLC 9930 MESA RIM ROAD San Diego, CA 92121 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-05 |
| Decision Date | 2016-10-21 |